Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-26 @ 7:25 PM
Study NCT ID:
NCT06544993
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goodman and Baron Qualitative Global Scarring Grading System:', 'timeFrame': '6 months', 'description': 'Acne scarring severity will be graded before and after treatment. Grade 1 (macular) erythematous, hyper/hypopigmented flat marks; Grade 2 (mild) mild atrophy or hypertrophic scars that may not be obvious at a distance of 50cm or greater \\& may be covered adequately by makeup or beard hair in men; Grade 3 (moderate) moderate atrophy or hypertrophic scarring obvious at a distance of 50cm or greater, not covered by makeup or beard hair but can be flattened by manual stretching of the skin; and Grade 4 (severe) severe atrophy or hypertrophic scarring not flattened by manual stretching of the skin.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophic Acne Scar']}, 'referencesModule': {'references': [{'pmid': '36169570', 'type': 'BACKGROUND', 'citation': 'Mohamed NE, Shabaan SN, Raouf AH. Microbotox (Mesobotox) versus microneedling as a new therapeutic modality in the treatment of atrophic post-acne scars. J Cosmet Dermatol. 2022 Dec;21(12):6734-6741. doi: 10.1111/jocd.15419. Epub 2022 Oct 14.'}, {'pmid': '36857534', 'type': 'BACKGROUND', 'citation': 'Fabi SG, Park JY, Goldie K, Wu W. Microtoxin for Improving Pore Size, Skin Laxity, Sebum Control, and Scars: A Roundtable on Integrating Intradermal Botulinum Toxin Type A Microdoses Into Clinical Practice. Aesthet Surg J. 2023 Aug 17;43(9):1015-1024. doi: 10.1093/asj/sjad044.'}, {'pmid': '33686358', 'type': 'BACKGROUND', 'citation': 'Jung JH, Jin SG. Microneedle for transdermal drug delivery: current trends and fabrication. J Pharm Investig. 2021;51(5):503-517. doi: 10.1007/s40005-021-00512-4. Epub 2021 Mar 4.'}, {'pmid': '35942010', 'type': 'BACKGROUND', 'citation': 'Ebrahim H, Elardi A, Khater S, Morsi H. Successful Topical Application of Botulinum Toxin After Microneedling Versus Microneedling Alone for the Treatment of Atrophic Post Acne Scars: A Prospective, Split-face, Controlled Study. J Clin Aesthet Dermatol. 2022 Jul;15(7):26-31.'}]}, 'descriptionModule': {'briefSummary': 'Post-acne scars are psychologically disappointing and therapeutically challenging condition. No standard treatment for atrophic acne scars.\n\nMicro-Botox, is a highly diluted BTX-A which could be injected safely intra-dermally. It targets the superficial fibers of facial muscles, sweat, and sebaceous glands inducing pores shrinkage, decreasing the sebum and excessive sweating, in addition to face lifting and reducing fine wrinkles without affecting emotions, this subsequently makes the skin tighter and gives the facial skin a smooth appearance.\n\nAlso, BTX-A appears to have an inhibitory effect on fibroblasts and collagen remodeling activity, in addition to releasing muscular tension at scar edges through superficial muscle relaxation. So, it can reduce the tethering and pulling effect of the muscles surrounding the acne scars. Also, it has anti-inflammatory and angiogenesis induction effects. Therefore, micro-Botox is believed to improve acne scars.\n\nTherefore, it will be interesting to compare the efficacy and safety of microneedling combined with BTX-A versus meso-Botox injection in the treatment of atrophic acne scars through a split-face clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrophic post-acne scars.\n\nExclusion Criteria:\n\n* Pregnancy and lactation. Ongoing infection within the targeted treatment region or active acne lesions. Skin cancer, or precancerous lesions. History of keloid formation. History of allergy to BTX. Patients with neuromuscular diseases, patients with pre-existing medical conditions that cause muscle weakness as myasthenia gravis.\n\nPatients who underwent Botox injection, during the last 6 months. Patients who were under treatment by systemic retinoids in the previous 6 months.\n\nPatients with a history of chemical peels or laser procedures within 6 months of the study period.\n\nPatients with bleeding disorders.'}, 'identificationModule': {'nctId': 'NCT06544993', 'briefTitle': 'Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study', 'orgStudyIdInfo': {'id': 'soh-Med-24-07-21MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'right side of face', 'description': 'meso-Botox injection', 'interventionNames': ['Drug: Meso-botox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'left side of face', 'description': 'microneedling combined with Botulinum toxin-A', 'interventionNames': ['Drug: Meso-botox']}], 'interventions': [{'name': 'Meso-botox', 'type': 'DRUG', 'otherNames': ['Micro-Botox'], 'description': 'Micro-Botox, is a highly diluted Botulinum toxin type A', 'armGroupLabels': ['left side of face', 'right side of face']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Sohag', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mariam N Latif, resident', 'role': 'CONTACT', 'email': 'mariam_nashaat_post@med.sohag.edu.eg', 'phone': '01228732523'}, {'name': 'Reham E El Dawla, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident AT DERMATOLOGY department-sohag general hospital', 'investigatorFullName': 'Mariam Nashaat latif', 'investigatorAffiliation': 'Sohag University'}}}}